| ZETA RX CORONARY STENT SYSTEM (P970020/S068) | Abbott Vascular, Inc. | 2011-09-27 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S002) | Cordis US Corporation | 2011-09-27 |
| MULTICETER AUTOMATIC DEFIBRILLATOR IMPLANT ATION YTRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY (P010012/S270) | Boston Scientific Corp | 2011-09-27 |
| XIENCE V RX & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S080) | Abbott Vascular, Inc. | 2011-09-27 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S018) | Boston Scientific Corp | 2011-09-27 |
| VISION RAPID EXCHANGE (RX) & MINI VISION RX MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (CSS) (P020047/S039) | Abbott Vascular | 2011-09-27 |
| EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S077) | Boston Scientific Scimed, Inc. | 2011-09-27 |
| VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM (P040016/S076) | Boston Scientific Scimed, Inc. | 2011-09-27 |
| TRIFECTA VALVE (P100029/S002) | ABBOTT MEDICAL | 2011-09-26 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S066) | Boston Scientific Corp | 2011-09-23 |
| NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION (P030031/S031) | Biosense Webster, Inc. | 2011-09-23 |
| PERCLOSE AT AND PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S075) | Abbott Vascular, Inc. | 2011-09-23 |
| FLEXTOME CUTTING BALLOON (P950020/S042) | Boston Scientific Corp | 2011-09-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S019) | Boston Scientific Corp | 2011-09-23 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S072) | Boston Scientific Scimed, Inc. | 2011-09-23 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S069) | Boston Scientific Scimed, Inc. | 2011-09-23 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S240) | Medtronic, Inc. | 2011-09-22 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S020) | Bard Peripheral Vascular | 2011-09-22 |
| RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM (P110001/S001) | Abbott Vascular | 2011-09-21 |
| PERIMOUNT BIOPROSTHESES (P860057/S079) | Edwards Lifesciences, LLC | 2011-09-21 |
| CAPSURE EPI EPICARDIAL PACING LEADS (P950024/S036) | Medtronic, Inc. | 2011-09-21 |
| CADENCE FAMILY OF ICDS (P910023/S265) | ABBOTT MEDICAL | 2011-09-20 |
| EPIC HF FAMILY OF CRT-DS (P030054/S190) | ABBOTT MEDICAL | 2011-09-20 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S022) | Bard Peripheral Vascular, Inc. | 2011-09-16 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S037) | W. L. Gore & Associates, Inc. | 2011-09-16 |
| ELECTROLESS NICKEL IMMERSION GOLD PROCESS (ENIG) PROCESS (P820003/S112) | Medtronic Cardiac Rhythm Disease Management | 2011-09-16 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S010) | Medtronic Vascular | 2011-09-16 |
| COGNIS CRT MODELS N118, N19 (P960040/S245) | Boston Scientific | 2011-09-15 |
| TELIGEN ICD MODELS E102, E103, E110, E111 (P010012/S271) | Boston Scientific Corp | 2011-09-15 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S011) | Medtronic Cryocath, LP | 2011-09-15 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S109) | Boston Scientific Corp | 2011-09-15 |
| FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE (P020045/S039) | Medtronic Cryocath, LP | 2011-09-15 |
| HANCOCK II PROCINE BIOPROSTHESIS (P980043/S033) | Medtronic, Inc. | 2011-09-14 |
| HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT (P790007/S031) | Medtronic Heart Valves | 2011-09-14 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S035) | Medtronic, Inc. | 2011-09-14 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S005) | Medtronic Vascular | 2011-09-14 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S040) | Medtronic, Inc. | 2011-09-14 |
| ANEURX STENT GRAFT SYSTEM (P990020/S034) | Medtronic Vascular | 2011-09-13 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S208) | ABBOTT MEDICAL | 2011-09-08 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S087) | ABBOTT MEDICAL | 2011-09-08 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S042) | ABBOTT MEDICAL | 2011-09-08 |
| EPIC HF / ATLAS + HF FAMILY OF CRT-DS (P030054/S197) | ABBOTT MEDICAL | 2011-09-08 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S272) | ABBOTT MEDICAL | 2011-09-08 |
| EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS (P030054/S198) | ABBOTT MEDICAL | 2011-09-08 |
| CADENCE FAMILY OF ICDS (P910023/S271) | ABBOTT MEDICAL | 2011-09-08 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS (P880006/S073) | St. Jude Medical, Inc. | 2011-09-08 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S016) | Boston Scientific Corp | 2011-09-07 |
| TALENT ENDOLUMINALOCCLUDER SYSTEM (P070027/S031) | Medtronic Vascular | 2011-09-07 |
| 5433 PATIENT CABLE PROXIMAL CONNECTOR AND MATERIAL (P820003/S111) | Medtronic Cardiac Rhythm Disease Management | 2011-09-07 |
| CAPSUREFIX MODELS 4076, 5076 (P930039/S062) | Medtronic, Inc. | 2011-09-07 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S058) | Medtronic, Ireland | 2011-09-07 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S007) | Medtronic Vascular | 2011-09-07 |
| CAPSUREFIX MODEL 5086MRI (P090013/S038) | Medtronic, Inc. | 2011-09-07 |
| TRIFECTA VALVE (P100029/S007) | ABBOTT MEDICAL | 2011-09-07 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S046) | Corcym S.r.l. | 2011-09-02 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S005) | Bard Peripheral Vascular, Inc. | 2011-09-02 |
| XACT CARTOID STENT SYSTEM (P040038/S023) | Abbott Vascular, Inc. | 2011-09-02 |
| RELIANCE 4-SITE LEADS (P910073/S094) | Boston Scientific | 2011-09-01 |
| RX ACCULINK SELF-EXPANDING STENT SYSTEM (P040012/S041) | Abbott Vascular | 2011-09-01 |
| ALTERNATE LASER SOURCE (P950029/S062) | MicroPort CRM USA, Inc. | 2011-09-01 |
| PACKAGED DIODES (P090013/S037) | Medtronic, Inc. | 2011-09-01 |
| VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES (P830060/S067) | Boston Scientific | 2011-09-01 |
| VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS (P910077/S117) | Boston Scientific | 2011-09-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (P020047/S038) | Abbott Vascular | 2011-09-01 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S079) | Abbott Vascular, Inc. | 2011-09-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S067) | Abbott Vascular, Inc. | 2011-09-01 |
| XACT CARTOID STENT SYSTEM (P040038/S022) | Abbott Vascular, Inc. | 2011-09-01 |
| ROTATIONAL ATHERECTOMY SYSTEM (P900056/S104) | Boston Scientific Corp | 2011-08-31 |
| REPLY/ESPRIT PACEMAKER IMPLANTABLE MEDICAL DEVICES (P950029/S061) | MicroPort CRM USA, Inc. | 2011-08-29 |
| XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S078) | Abbott Vascular, Inc. | 2011-08-25 |
| MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH (P890003/S228) | Medtronic, Inc. | 2011-08-25 |
| ROTABLATOR TOTATIONAL ATHERECTOMY SYSTEM (P900056/S108) | Boston Scientific Corp | 2011-08-25 |
| FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS (P970031/S034) | Medtronic, Inc. | 2011-08-25 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S032) | Medtronic, Inc. | 2011-08-25 |
| HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105 (P790007/S030) | Medtronic Heart Valves | 2011-08-25 |
| MOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310 (P990064/S039) | Medtronic, Inc. | 2011-08-25 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S001) | Cordis US Corporation | 2011-08-25 |
| PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S073) | Abbott Vascular, Inc. | 2011-08-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S039) | W. L. Gore & Associates, Inc. | 2011-08-23 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S064) | Abbott Vascular, Inc. | 2011-08-23 |
| ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM (P100010/S001) | Medtronic Cryocath, LP | 2011-08-23 |
| CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S271) | Medtronic Cardiac Rhythm Disease Management | 2011-08-19 |
| REVO MRI (P090013/S035) | Medtronic, Inc. | 2011-08-19 |
| MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II (P980016/S317) | Medtronic Cardiac Rhythm Disease Management | 2011-08-19 |
| SYNCRA CRT-P, CONSULTA CRT-P (P010015/S137) | Medtronic, Inc. | 2011-08-19 |
| ENRHYTHM (P980035/S239) | Medtronic, Inc. | 2011-08-19 |
| TALENT THORACIC STENT GRAFT WITH THE XCELERANT AND CAPTIVIA DELIVERY SYSTEM (P070007/S029) | Medtronic Vascular | 2011-08-18 |
| ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P990020/S045) | Medtronic Vascular | 2011-08-18 |
| (D334TRG), PROTECTA XT (D314TRG) (P010031/S272) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| REPLY/ESPRIT (P950029/S060) | MicroPort CRM USA, Inc. | 2011-08-18 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S004) | Medtronic Vascular | 2011-08-18 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P070027/S029) | Medtronic Vascular | 2011-08-18 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II (P980016/S298) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S030) | Boston Scientific | 2011-08-18 |
| CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S252) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG) (P980016/S318) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-PS (P030035/S086) | ABBOTT MEDICAL | 2011-08-17 |
| CADENCE/CURRENT/FORTIFY FAMILY OF ICDS (P910023/S267) | ABBOTT MEDICAL | 2011-08-17 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S041) | ABBOTT MEDICAL | 2011-08-17 |
| EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS (P030054/S193) | ABBOTT MEDICAL | 2011-08-17 |